The Scope Scare
By John Roark and Kathy Dix
News running in the New York Times and posted on CNN.com sent a shiver through the public consciousness when a story was released that North Shore University Hospital in Manhasset, N.Y., may have exposed patients to HIV and hepatitis virus because instruments used for routine endoscopies might not have been properly disinfected.
The story, originally published on June 16, 2004, reported that hospital officials discovered a 12-day stretch beginning April 28 during which there was no record of employees having tested disinfectant used to clean the scopes. Letters were sent out to the 177 patients who had undergone endoscopic procedures during that time period, recommending testing for hepatitis B, hepatitis C and HIV.
According to the Times article, Terry Lynam, a spokesman for the North Shore-Long Island Jewish Health System said, The letter was undoubtedly unsettling. But were trying to ease those concerns by raising what is a miniscule likelihood that any of these infections could be transmitted. This is the first time its ever happened at this hospital.
The actual risk of infection is small, says Lawrence Muscarella, PhD, chief of infection control for Custom Ultrasonics, Inc., provided scopes are adequately cleaned. Its just amazing how fragile these viruses are, he says. The literature suggests that if you do cleaning properly you wont have transmission of HIV or hepatitis B or C irrespective of any disinfection. In the cases where hepatitis has been transmitted, cleaning has been inadequate. So we have instances where cleaning is adequate, but the disinfection is either not being done, or being done inadequately, and we dont have disease transmission documented yet. Thats why the risk of a bacterial infection is much higher. The risk of a viral infection remains fortunately very low, provided cleaning is done.
Facilities practicing strict adherence to published guidelines may wonder how such a gaffe could take place. You can use our disinfectant for up to two weeks, but no longer than that, and it has to be tested every day for its strength, says Bernadette Murray, an endoscopy technician at Fletcher Allen Health Care in Burlington, Vt. We set a standard years ago of testing with a chem stick every day, first thing in the morning before any scopes are done. With our automatic washer, you lose a little bit of disinfectant with every cycle and its diluted out just a little bit with each cycle as well, because theres wetness in the processing chamber where the scope is.
The faithful record-keeping has paid off. Ive worked in this department for 13 years as an endoscopy tech, and in that time, I havent known of any infections transmitted through a scope to a patient. I dont ever want to see one, either. When I teach people to clean the scope, I make them feel the same as I do: youre cleaning the scope as if its going to be used on you or some member of your family. You dont want to take any shortcuts, no matter how busy it is. It isnt all about speed; you want to do a good job, she says.
Im proud of the hospital if it noticed that there could potentially be a problem for notifying the patients about it, says Cathy Dykes, MS, RN, CCRC, CGRN, president of the Society of Gastroenterology Nurses and Associates (SGNA).
Christine Nutty, RN, MSN, CIC, an infection control practitioner at Western Baptist Hospital in Paducah, Ky., and member of the Association of Infection Control and Practitioners (APIC) board of directors, agrees. I think its really good in a lot of ways. I think its good that CNN got ahold of this to help get the word out.
On the other hand, many infection control practitioners were not stunned by the news. Unfortunately, Im not surprised, says Muscarella, citing similar items published recently in the Sacramento Bee and The Seattle Times, which reported as many as 800 patients in one hospital and 1,000 in another being similarly exposed. Basically it goes back to funding, with hospitals using untrained medical staff to reprocess endoscopes. Endoscopes are somewhat unique in the extent to which they can transmit disease to many patients in a short period of time due to their use and their high cost. Its an issue of funding.
It doesnt surprise me in terms of what I see in too many healthcare facilities today, says Nancy Chobin, RN, CSPDM, the CS/SPD educator for the Saint Barnabas Health Care System in West Orange, N.J. Should it happen? Absolutely not. In my opinion, this is the worst evidence of practice for patient safety, and with all of the focus on patient safety today, testing a high level disinfectant before use should be like rolling out of bed. You shouldnt even have to think about it. How someone would use a solution without testing it first is beyond me, and to go for 12 days without anybody questioning it I heard one news report that one person was terminated, and the other person was disciplined, and if thats the case, I support that decision because not testing the solution can be considered malpractice. If this is an issue of people not being trained properly, then the hospital is at fault. If its the individual who was trained, but just forgot or didnt think it was important, then the individual(s) are at fault.
In playing the blame game, where should the finger be pointed? Lack of funding, under-trained medical staff, unclear FDA regulation on disinfectants and complacency among processing personnel are all mitigating factors. Not surprisingly, the spectrum of opinion is diverse.
Ultimately it needs to come from the top down, says Nutty. Management of the facility needs to support following the appropriate infection control principles. Thats something that some facilities do, and others do not. Part of the problem is the endoscopy world is under such pressure now because of Katie Couric and everybody getting colonoscopies done. Its wonderful for their business, but in a way it has made them almost go into assembly-line production. You can speed up your production, but if you dont monitor the quality, then somebody suffers, and it will be the patient. They have to have good principles of infection control I think that is ultimately what is mandated. Thats why I think this is good because it does bring it to light to the public the public needs to be knowledgeable about this.
Muscarella is vocal about blurred FDA regulations. Everyone is saying youve got to monitor the glutaraldehyde more often. The guidelines have always been unclear. The Society of Gastroenterology Nurses and Associates (SGNA) guidelines say to monitor the glutaraldehyde once a day or more, depending on usage. The label says monitor the glutaraldehyde before each use. So theres confusion about that.
The FDA is not to blame; the manufacturer is not to blame, says Chobin. Theres no competency testing. With every single procedure we do, there should be a return demonstration. Instead, a sales rep comes in, gives you a short in-service, and we expect people to remember it. I might not be using that solution for three or four weeks, because we dont use it every day. Im not going to remember. If you gave me a competency return demonstration, where you tell one, show one, do one, then youre going to remember how to do it. There should be some kind of check sheet posted, so if you dont remember, its there. If I dont take advantage of that, then shame on me.
I think all the entities have a stake in a good outcome, says Douglas Nelson, MD, physician spokesperson for the American Society of Gastrointestinal Endoscopists (ASGE), staff physician in gastroenterology at the Minneapolis VA Medical Center and associate professor of medicine at the University of Minnesota Medical School. All groups should play a part in trying to minimize this sort of reprocessing failure in the future. Whos ultimately responsible? I think its the physician.
Ultimately, Im responsible for the equipment I use. That may devolve onto my endoscopy nurse who runs the reprocessing unit; it may devolve onto the tech who actually reprocesses the endoscope, but ultimately, its the physician. Its the gastroenterologist who is doing the procedure who is ultimately going to be tagged or labeled with the adverse outcome. The institution might be listed in legal action because they have deep pockets. But its the physician whos going to have to assume responsibility.
Anomaly or Norm?
Among infection control practitioners, questions arise. Who ultimately should be held accountable for such an egregious lapse in disinfection and processing protocol? Is this news item indicative of a widespread crisis in infection control?
Obviously, this is happening in many places and simply not making the news, points out Chobin, who can immediately recall three separate cases of poor scope sterilization. I was in a hospital, maybe a year and a half ago, and it was not in CS or the OR; it was another department. There are two dates on the product: one is shelf life, which is the date you have to open the bottle by, and its usually a couple years from the time you purchase it. Then theres a use life. Once you open the bottle, its usually good for 14 or 28 days, depending on the formulation. They were using a solution and fortunately they still had the jug that had expired two years before. Not only were they using a solution that had expired, but they werent testing it either. Had they tested it, they would have found that it was no good.
It gets worse, as Chobin relates an incident at a second hospital. In order to fully disinfect, youre supposed to have the item completely immersed. They thought, Well, we dont have the right container. Why spend the money for the right container? So they just took a towel and put it on top of the device that was sticking out from the container and soaked it with the Cidex and thought that was sufficient.
But wait theres more. At the third hospital, the product was still good on the 15th day. So they figured, If its still testing good, we can continue to use it. No! If the manufacturer says you must discard it at 14 days, if not sooner, depending on your testing, then you throw it out.
In any healthcare system youre dealing with human beings, and youre going to have some people who are complacent, and some who are sticklers to good quality, says Nutty. Of course I think it goes on. Anyone who thinks that this cant happen needs to look closely to their own system, because it can and obviously does.
Muscarella likens the elements contributing to the Manhasset hospital as a perfect storm. You have an instrument that cant be steam autoclaved, you have an instrument thats expensive, so you have only a few of them. As a result of having few of them, you end up using one scope on many patients throughout the day. So you have complacency, the design of the instrument, poor funding, poor education you have all of these independent satellites colliding at once. This is whats going to end up happening.
With all the ground endoscopy has gained in public awareness, will it be derailed by the publicity of the Manhasset event? The concern I would have about the adverse media coverage, is that there is a tremendous documented value to endoscopy, says Nelson. We know that if we do screening colonoscopy, approximately 1 percent of patients over the age of 50 will have a cancer that was previously unrecognized. Across the United States, 50,000 people will die of colorectal cancer, which is largely a preventable disease. I would be concerned that patients might avoid a potentially life-saving procedure for fear of a very unsubstantiated risk that is estimated to be at less than one in a million. I think its important that, while the media may serve to keep everybody honest and make sure that these failures get corrected, we shouldnt throw the baby out with the bath water and end up doing more overall harm than good. We need to correct the system, but we also need to keep this in perspective, that the risk of infection is vanishingly small. There are no cases of transmission of infection reported when currently accepted guidelines have been followed, ever. Theres never been a case reported when everyone followed the guidelines and theres been a transmission of infection.
Keep the big picture in perspective. This is a life-saving procedure; dont avoid the procedure because of an unwarranted fear.